Scientist I Quality Control

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most home to hospital lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as one QuidelOrtho we are seeking a Serologist I to support our Immunohematology products. This person will be responsible for testing raw materials in process bulk testing on Immunohematology products. This person will assure compliance with company standards and applicable regulatory agencies. You will be responsible to participate in failure investigations to help determine root cause track and trend data identify and suggest process improvements to improve business measures.

This is an onsite position located in Pompano Beach Florida.

Work Schedule: Second Shift/ Flexible :

• This will be a second shift position with flexibility to work weekends over time and fluctuation on start time (a couple of hours earlier or later) to accommodate business needs. Strong preference for candidates demonstrating flexibility in working any shift (day and night shifts plus weekends) over time and fluctuation on start time to accommodate business needs.

The Responsibilities

• Organizes and performs product release stability and raw material testing under direct supervision.

• Performs testing within established timelines and in accordance with current specifications.

• Documents results clearly and accurately. Interprets results by complying to appropriate specification requirements.

• Perform data trending of critical product process information and release test results to be used in SPC/ trend analysis.

• Maintains sufficient inventories off reagents and supplies.

• Assures compliance to company procedures GMP FDA Safety and ISO regulations in all functions.

• Participate in laboratory investigations technology transfer validation and R&D projects.

• Performs additional work-related duties as assigned.

The Individual

Required:

• Bachelors degree in Medical Technology Clinical laboratory Science Biology Chemistry or related field of study.

• Knowledge and experience with Good Manufacturing Practices (GMP)

• Proficiency with Microsoft Office Suite of products

• Knowledge and experience with Good Documentation Practices (GDP)

• Pipetting

• Perform Indirect Antiglobulin Testing (IAT)

• Perform Direct Antiglobulin Testing (DAT)

• Grading Blood Bank reactions

• Perform Instrument maintenance

• Perform titrations

• Quality Control

• Reverse Blood grouping

Preferred:

• Blood Bank Tube Testing

• Blood Bank Instrument Testing

The Key Working Relationships

• Internal Partners: Strong working relationships with the sites Material Management Quality Upstream Formulation EHS Facilities Engineering Product Support are necessary to drive effective prioritization and collaboration to meet the needs of the business

• External Partners: Suppliers

The Work Environment

The work environment characteristics are representative of an office laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk analyzing data in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

Physical Demands

Manual dexterity to handle instruments complete repetitive motions and stand for long periods of time is required. Including sitting standing walking bending squatting balancing (Maintaining body equilibrium to prevent falling when walking standing or crouching on narrow slippery or erratically moving surfaces. Amount and kind of balancing exceeds that needed for ordinary locomotion and maintenance of body equilibrium) and ability to lift up to 30lbs.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals including individuals with disabilities have an opportunity to apply for those positions that they are interested in and qualify for without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability please contact us at .

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